Senior Director, Regulatory Affairs – Advertising & Promotion

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Summit Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2003

🏥 Healthcare

💼 Consulting

📣 Marketing

🔥 Funding within the last year

💰 $500M Post-IPO Equity - Summit Therapeutics on 2025-10

Healthcare • Consulting • Marketing

Summit Therapeutics, Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of novel medicinal therapies to improve quality and duration of life for patients with serious unmet medical needs. The company is advancing ivonescimab (SMT112), a novel bispecific antibody targeting PD-1 and VEGF, through multiple Phase 3 clinical trials for non-small cell lung cancer and other solid tumors under license from Akeso. Summit emphasizes clinical development, regulatory filing strategies, and potential commercialization in its licensed territories while promoting patient- and caregiver-friendly treatment options.

📋 Description

• Evaluate Commercial, Legal/Compliance, and Medical perspectives and provide expert regulatory guidance on promotional, disease state education, corporate, and other non-promotional materials • Review materials in Veeva and participate in Medical Review Committee and Promotional Review Committee meetings • Review and interpret enforcement actions and FDA Guidance to Industry documents • Contribute to internal MRC/PRC processes ensuring materials comply with FDA regulations • Provide guidance on process enhancements, compliance, and process efficiencies • Develop and implement regulatory advertising and promotion strategy and manage complex negotiations • Guide communications with healthcare professionals, patients/consumers, payers, executive management, and other audiences • Facilitate submission of branded promotional materials to FDA on Form 2253 • Act as the main point of contact with FDA's Office of Prescription Drug Promotion • Advise management and cross-functional teams on relevant laws, regulations, guidelines, and standards • Ensure corporate goals are met for assigned projects • Represent Regulatory Affairs independently under direction of the Vice President of Regulatory Affairs • Potentially manage direct reports and contribute to performance management for other Regulatory Affairs team members • Participate in professional associations, industry, and trade groups as appropriate • Follow budget allocations

🎯 Requirements

• Bachelor's degree in a scientific discipline and 12+ years of related experience, or equivalent combination of education and experience • Advanced degree (MS, PharmD) preferred • Strong Regulatory Advertising and Promotion knowledge • Demonstrated success preparing and submitting regulatory documents • Strong understanding of Advertising and Promotion and regulatory requirements for prescription-drug promotion • Experienced user of the Veeva ecosystem for Promotional Review Committee-related items • Strong communication and proactive negotiation skills • Ability to communicate effectively and articulate complex ideas clearly • Ability to work successfully in a fast-paced, demanding, and collaborative environment • Willingness to travel up to approximately 5%

🏖️ Benefits

• Bonus, stock, benefits and/or other applicable variable compensation may be included in the total compensation package • Travel up to approximately 5%